Merit Medical convenience kits with syringe quality issues recalled nationwide
Merit Medical is recalling convenience kits containing syringes with quality issues including leaks and breakage that may pose a risk to patients receiving intravenous fluid administration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical devices with identified quality issues (leaks and breakage) in components used for patient fluid administration. Although no illnesses or injuries are reported in the source text, the potential for harm during patient care exists, classifying this as a risk-of-harm product without yet-reported injury per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling various convenience kits (models K08-PI and catalog numbers K08-02042, K08-02948, K08-03026, and K08-03119) that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The recalled syringes are components of intravascular administration sets, which are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Quality issues have been identified with the syringes, including leaks and breakage, that may pose a risk to patient health. The issues were identified in an FDA Safety Alert issued on March 19, 2024.
The recall affects 3,694 kits that were distributed nationwide across all 50 U.S. states and the District of Columbia. Specific affected lot numbers are listed by catalog number in the FDA notice.
Healthcare providers and facilities should identify and quarantine affected kits immediately. Patients who may have received treatment with affected syringes should contact their healthcare provider.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 3,694
Distribution
Part of a larger recall action
This product is one of 23 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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